Class Class II
31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil (K213480)
Description
31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil by Rapid Biomedical GmbH, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK213480
Clearance Date2023-02-01
Clearance TypeTraditional
Product CodeMOS
Regulation Number892.1000
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213480
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil (K213480) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K102748 | 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T | Rapid Biomedical GmbH | 2011 |
Trace the full predicate network for K213480
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.